Trial Outcomes & Findings for Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain (NCT NCT01216163)
NCT ID: NCT01216163
Last Updated: 2012-08-20
Results Overview
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
COMPLETED
PHASE3
218 participants
0 to 6 hours
2012-08-20
Participant Flow
Participant milestones
| Measure |
Placebo
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
88
|
85
|
|
Overall Study
COMPLETED
|
44
|
87
|
85
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
Baseline Characteristics
Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
19.2 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
19.2 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
19.1 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
19.2 years
STANDARD_DEVIATION 2.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Number of Participants with Pain Severity Score
Moderate
|
33 participants
n=5 Participants
|
64 participants
n=7 Participants
|
60 participants
n=5 Participants
|
157 participants
n=4 Participants
|
|
Number of Participants with Pain Severity Score
Severe
|
12 participants
n=5 Participants
|
24 participants
n=7 Participants
|
25 participants
n=5 Participants
|
61 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0 to 6 hoursPopulation: Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)
|
2.8 units on a scale
Standard Deviation 9.9
|
20.0 units on a scale
Standard Deviation 11.6
|
17.1 units on a scale
Standard Deviation 11.9
|
PRIMARY outcome
Timeframe: 0 to 6 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Time to Onset of Meaningful Relief
|
NA minutes
Data was not summarized as median time to meaningful effect was greater than (\>) 360 minutes for Placebo group and therefore 95% CI was not estimable.
|
58.0 minutes
Interval 41.4 to 74.8
|
53.4 minutes
Interval 48.6 to 69.1
|
SECONDARY outcome
Timeframe: 0 to 6 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Time to Confirmed First Perceptible Relief
|
NA minutes
Data was not summarized as median time to first confirmed perceptible relief was \>360 minutes for Placebo group and therefore 95% CI was not estimable.
|
16.0 minutes
Interval 15.7 to 26.8
|
23.7 minutes
Interval 19.0 to 29.3
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
PRR was evaluated at different time points during the study up to 6 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Pain Relief Rating (PRR)
0.25 hours
|
0.1 units on a scale
Standard Deviation 0.4
|
0.7 units on a scale
Standard Deviation 0.8
|
0.4 units on a scale
Standard Deviation 0.7
|
|
Pain Relief Rating (PRR)
0.5 hours
|
0.3 units on a scale
Standard Deviation 0.6
|
1.8 units on a scale
Standard Deviation 1.2
|
1.5 units on a scale
Standard Deviation 1.1
|
|
Pain Relief Rating (PRR)
1 hour
|
0.6 units on a scale
Standard Deviation 0.8
|
2.6 units on a scale
Standard Deviation 1.1
|
2.4 units on a scale
Standard Deviation 1.2
|
|
Pain Relief Rating (PRR)
1.5 hours
|
0.5 units on a scale
Standard Deviation 0.9
|
2.8 units on a scale
Standard Deviation 1.1
|
2.5 units on a scale
Standard Deviation 1.2
|
|
Pain Relief Rating (PRR)
2 hours
|
0.5 units on a scale
Standard Deviation 1.1
|
2.8 units on a scale
Standard Deviation 1.2
|
2.5 units on a scale
Standard Deviation 1.4
|
|
Pain Relief Rating (PRR)
3 hours
|
0.5 units on a scale
Standard Deviation 1.1
|
2.5 units on a scale
Standard Deviation 1.4
|
2.2 units on a scale
Standard Deviation 1.5
|
|
Pain Relief Rating (PRR)
4 hours
|
0.5 units on a scale
Standard Deviation 1.2
|
2.4 units on a scale
Standard Deviation 1.5
|
2.1 units on a scale
Standard Deviation 1.6
|
|
Pain Relief Rating (PRR)
5 hours
|
0.5 units on a scale
Standard Deviation 1.2
|
2.0 units on a scale
Standard Deviation 1.5
|
1.9 units on a scale
Standard Deviation 1.6
|
|
Pain Relief Rating (PRR)
6 hours
|
0.5 units on a scale
Standard Deviation 1.2
|
2.0 units on a scale
Standard Deviation 1.6
|
1.7 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 \[none\] to 3 \[severe\]) from the baseline score (Baseline pain severity score range 2 \[moderate\] to 3 \[severe\]). Total possible score range for PID: -1 (worst) to 3 (best).
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Pain Intensity Difference (PID)
0.25 hours
|
-0.1 units on a scale
Standard Deviation 0.3
|
0.3 units on a scale
Standard Deviation 0.5
|
0.2 units on a scale
Standard Deviation 0.5
|
|
Pain Intensity Difference (PID)
0.5 hours
|
-0.1 units on a scale
Standard Deviation 0.4
|
0.8 units on a scale
Standard Deviation 0.7
|
0.5 units on a scale
Standard Deviation 0.7
|
|
Pain Intensity Difference (PID)
1 hour
|
0.0 units on a scale
Standard Deviation 0.6
|
1.3 units on a scale
Standard Deviation 0.8
|
1.0 units on a scale
Standard Deviation 0.8
|
|
Pain Intensity Difference (PID)
4 hours
|
-0.0 units on a scale
Standard Deviation 0.8
|
1.1 units on a scale
Standard Deviation 1.0
|
0.9 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID)
5 hours
|
0.0 units on a scale
Standard Deviation 0.9
|
0.9 units on a scale
Standard Deviation 1.0
|
0.8 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID)
6 hours
|
-0.0 units on a scale
Standard Deviation 0.9
|
0.9 units on a scale
Standard Deviation 1.1
|
0.6 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID)
1.5 hours
|
-0.0 units on a scale
Standard Deviation 0.7
|
1.3 units on a scale
Standard Deviation 0.8
|
1.1 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID)
2 hours
|
-0.0 units on a scale
Standard Deviation 0.8
|
1.3 units on a scale
Standard Deviation 0.9
|
1.1 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference (PID)
3 hours
|
-0.0 units on a scale
Standard Deviation 0.9
|
1.2 units on a scale
Standard Deviation 1.0
|
0.9 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 \[none\] to 3 \[severe\]) from the baseline score (Baseline pain severity score range 2 \[moderate\] to 3 \[severe\]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
0.25 hours
|
0.1 units on a scale
Standard Deviation 0.5
|
0.9 units on a scale
Standard Deviation 1.3
|
0.6 units on a scale
Standard Deviation 1.1
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
0.5 hours
|
0.2 units on a scale
Standard Deviation 0.8
|
2.5 units on a scale
Standard Deviation 1.8
|
2.0 units on a scale
Standard Deviation 1.7
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
1 hour
|
0.6 units on a scale
Standard Deviation 1.3
|
3.9 units on a scale
Standard Deviation 1.8
|
3.4 units on a scale
Standard Deviation 1.9
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
1.5 hours
|
0.5 units on a scale
Standard Deviation 1.5
|
4.1 units on a scale
Standard Deviation 1.9
|
3.7 units on a scale
Standard Deviation 2.0
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
2 hours
|
0.5 units on a scale
Standard Deviation 1.8
|
4.1 units on a scale
Standard Deviation 2.0
|
3.6 units on a scale
Standard Deviation 2.3
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
3 hours
|
0.4 units on a scale
Standard Deviation 1.9
|
3.7 units on a scale
Standard Deviation 2.3
|
3.1 units on a scale
Standard Deviation 2.4
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
4 hours
|
0.5 units on a scale
Standard Deviation 1.9
|
3.6 units on a scale
Standard Deviation 2.4
|
3.0 units on a scale
Standard Deviation 2.4
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
5 hours
|
0.5 units on a scale
Standard Deviation 2.1
|
2.9 units on a scale
Standard Deviation 2.5
|
2.7 units on a scale
Standard Deviation 2.5
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
6 hours
|
0.5 units on a scale
Standard Deviation 1.9
|
2.8 units on a scale
Standard Deviation 2.6
|
2.3 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 0 to 2, 0 to 3, 0 to 6 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
SPID: time-weighted sum of PID over 2, 3 and 6 hours. Total score range: -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, and -6 (worst) to 18 (best) for SPID 0-6. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best).
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID 0-6
|
-0.1 units on a scale
Standard Deviation 4.4
|
6.3 units on a scale
Standard Deviation 5.0
|
5.1 units on a scale
Standard Deviation 4.6
|
|
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID 0-2
|
-0.1 units on a scale
Standard Deviation 1.1
|
2.2 units on a scale
Standard Deviation 1.4
|
1.8 units on a scale
Standard Deviation 1.4
|
|
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID 0-3
|
-0.1 units on a scale
Standard Deviation 1.9
|
3.4 units on a scale
Standard Deviation 2.3
|
2.8 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 0 to 2, 0 to 3, 0 to 6 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
TOTPAR: time-weighted sum of PRR over 2, 3, and 6 hours. Total score range: 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, and 0 (worst) to 24 (best) for TOTPAR 0-6. PRR was evaluated at different time points during the study up to 6 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR 0-2
|
0.9 units on a scale
Standard Deviation 1.4
|
4.7 units on a scale
Standard Deviation 1.9
|
4.2 units on a scale
Standard Deviation 2.0
|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR 0-3
|
1.4 units on a scale
Standard Deviation 2.5
|
7.2 units on a scale
Standard Deviation 3.1
|
6.4 units on a scale
Standard Deviation 3.4
|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR 0-6
|
2.9 units on a scale
Standard Deviation 5.9
|
13.6 units on a scale
Standard Deviation 7.0
|
12.0 units on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: 0 to 2, 0 to 3 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
SPRID: time-weighted sum of PRID over 2 and 3 hours. Total score range: -2 (worst) to 14 (best) for SPRID 0-2, and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
SPRID 0-2
|
0.9 units on a scale
Standard Deviation 2.4
|
6.9 units on a scale
Standard Deviation 3.1
|
6.0 units on a scale
Standard Deviation 3.3
|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
SPRID 0-3
|
1.3 units on a scale
Standard Deviation 4.2
|
10.6 units on a scale
Standard Deviation 5.2
|
9.1 units on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment participant first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Cumulative Percentage of Participants With Meaningful Relief
0.25 hours
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
0.5 hours
|
0.0 percentage of participants
|
21.6 percentage of participants
|
20.0 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
1 hour
|
0.0 percentage of participants
|
53.4 percentage of participants
|
56.5 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
1.5 hours
|
2.2 percentage of participants
|
72.7 percentage of participants
|
64.7 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
2 hours
|
8.9 percentage of participants
|
75.0 percentage of participants
|
70.6 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
5 hours
|
13.3 percentage of participants
|
79.5 percentage of participants
|
74.1 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
6 hours
|
13.3 percentage of participants
|
79.5 percentage of participants
|
74.1 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
3 hours
|
11.1 percentage of participants
|
77.3 percentage of participants
|
71.8 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
4 hours
|
13.3 percentage of participants
|
78.4 percentage of participants
|
74.1 percentage of participants
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Percentage of participants with first perceptible relief evaluated by stopping the stopwatch labeled 'first perceptible relief' at the moment participant first began to experience any relief. First perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
0.25 hours
|
2.2 percentage of participants
|
28.4 percentage of participants
|
24.7 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
0.5 hours
|
4.4 percentage of participants
|
64.8 percentage of participants
|
62.4 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
1 hour
|
11.1 percentage of participants
|
78.4 percentage of participants
|
72.9 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
1.5 hours
|
11.1 percentage of participants
|
79.5 percentage of participants
|
74.1 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
2 hours
|
13.3 percentage of participants
|
79.5 percentage of participants
|
74.1 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
3 hours
|
13.3 percentage of participants
|
79.5 percentage of participants
|
74.1 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
4 hours
|
13.3 percentage of participants
|
79.5 percentage of participants
|
74.1 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
5 hours
|
13.3 percentage of participants
|
79.5 percentage of participants
|
74.1 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
6 hours
|
13.3 percentage of participants
|
79.5 percentage of participants
|
74.1 percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 6 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Time to Treatment Failure
|
1.6 hours
Interval 1.4 to 1.9
|
NA hours
Data was not summarized as median time to treatment failure was \>6 hours for Ibuprofen sodium group and therefore 95% CI was not estimable.
|
NA hours
Data was not summarized as median time to treatment failure was \>6 hours for Acetaminophen group and therefore 95% CI was not estimable.
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Cumulative Percentage of Participants With Treatment Failure
0.25 hours
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
1.5 hours
|
42.2 percentage of participants
|
2.3 percentage of participants
|
2.4 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
2 hours
|
68.9 percentage of participants
|
5.7 percentage of participants
|
12.9 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
3 hours
|
82.2 percentage of participants
|
11.4 percentage of participants
|
21.2 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
0.5 hours
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
1 hour
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
4 hours
|
82.2 percentage of participants
|
15.9 percentage of participants
|
27.1 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
5 hours
|
82.2 percentage of participants
|
25.0 percentage of participants
|
32.9 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
6 hours
|
82.2 percentage of participants
|
29.5 percentage of participants
|
35.3 percentage of participants
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Cumulative Percentage of Participants With Complete Relief
0.25 hours
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.2 percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
0.5 hours
|
0.0 percentage of participants
|
6.8 percentage of participants
|
4.7 percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
1 hours
|
0.0 percentage of participants
|
23.9 percentage of participants
|
15.3 percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
1.5 hours
|
0.0 percentage of participants
|
29.5 percentage of participants
|
24.7 percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
2 hours
|
4.4 percentage of participants
|
36.4 percentage of participants
|
29.4 percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
3 hours
|
4.4 percentage of participants
|
42.0 percentage of participants
|
32.9 percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
4 hours
|
6.7 percentage of participants
|
45.5 percentage of participants
|
35.3 percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
5 hours
|
8.9 percentage of participants
|
45.5 percentage of participants
|
35.3 percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
6 hours
|
8.9 percentage of participants
|
46.6 percentage of participants
|
35.3 percentage of participants
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Participant global evaluation of study medication was performed at the 6-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent.
Outcome measures
| Measure |
Placebo
n=45 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 Participants
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Participant Global Evaluation of Study Medication
|
0.9 units on a scale
Standard Deviation 1.3
|
3.5 units on a scale
Standard Deviation 1.3
|
3.0 units on a scale
Standard Deviation 1.5
|
Adverse Events
Placebo
Ibuprofen Sodium
Acetaminophen
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=45 participants at risk
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
|
Ibuprofen Sodium
n=88 participants at risk
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
|
Acetaminophen
n=85 participants at risk
Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
2.2%
1/45
|
2.3%
2/88
|
5.9%
5/85
|
|
Nervous system disorders
Headache
|
2.2%
1/45
|
1.1%
1/88
|
3.5%
3/85
|
|
Nervous system disorders
Somnolence
|
2.2%
1/45
|
0.00%
0/88
|
2.4%
2/85
|
|
Nervous system disorders
Paraesthesia
|
2.2%
1/45
|
0.00%
0/88
|
0.00%
0/85
|
|
Nervous system disorders
Tremor
|
2.2%
1/45
|
0.00%
0/88
|
0.00%
0/85
|
|
Gastrointestinal disorders
Nausea
|
13.3%
6/45
|
2.3%
2/88
|
7.1%
6/85
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45
|
1.1%
1/88
|
2.4%
2/85
|
|
General disorders
Hyperhidrosis
|
2.2%
1/45
|
0.00%
0/88
|
1.2%
1/85
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.2%
1/45
|
0.00%
0/88
|
0.00%
0/85
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
1/45
|
0.00%
0/88
|
0.00%
0/85
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER